System and method for pelvic floor procedures

ABSTRACT

A delivery device for tissue anchor delivery is provided. The delivery device includes a first flexible tube having a rigid distal portion attachable to a tissue anchor, a second flexible tube coaxially disposed around the first tube and a tubular sheath covering the second flexible tube. Also provided is a system which includes an imaging device coupler reversibly attached to the delivery device through guides.

RELATED APPLICATION

This application claims the benefit of priority under 35 USC 119(e) ofU.S. Provisional Patent Application No. 61/989,623 filed on May 7, 2014,the contents of which are incorporated herein by reference in theirentirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to a system and method for rapid, safe andaccurate access to pelvic floor tissues with minimal tissue trauma.Embodiments of the present invention relate to a system capable ofguiding and anchoring a tissue repair device and/or implant in treatmentin pelvic floor tissue.

Trans-vaginal pelvic floor repair is a surgical procedure which utilizesblunt tissue dissection to provide access to the sacrospinous ligamentfrom the posterior vaginal wall. A sling or mesh is then anchored to thesacrospinous ligament and the vaginal apex or the uterine isthmicalfibrotic ring, cervix or body, to thereby support prolapsing tissuesand/or organs.

Although pelvic floor repair is a common procedure, access to thesacrospinous ligament is typically effected by improvised manual bluntdissection techniques and/or use of off the shelf instruments.

Centro-apical reconstruction is the key for proper pelvic organ prolapse(POP) repair. The premium supportive pelvic structure is thesacrospinous ligament (SSL) which is positioned at the posterior aspectof the pelvis. The SSL is a robust ligament and thus provides a longlasting solution. Since it is positioned high in the pelvis and mediallythe SSL provides a level 1 support (DeLancey) and reduces the likelihoodof dyspareunia when utilized for prolapse repair.

Vaginal wall access to the SSL can be difficult and hazardous sinceorgans and tissues surrounding the access path can easily be injuredduring dissection. Present day approach for accessing the SSL startswith an incision at the mid-line of the posterior or anterior vaginalwall followed by lateral dissection under the sub-mucosal fascia to thepelvic side wall and dissection towards the ischial spine to the mid SSL(MSSL).

This approach decreases risk of tissue injury by bypassing thebladder/rectum while maintaining accurate navigation along the abovementioned landmarks. Such an approach requires a high degree of skilland as such can lead to a high rate of complications; this prompted theFDA to issue a significant risk warning associated with POPreconstruction.

While reducing the present invention to practice, the present inventorshave devised a system and method which can be used to deliver a tissueanchor to anatomical landmarks and structures such as the ischial spineand the sacrospinous ligament from the vaginal cavity.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided adevice for tissue anchor delivery comprising: (a) a first flexible tubehaving a rigid distal portion attachable to a tissue anchor; (b) asecond flexible tube coaxially disposed around the first tube; and (c) atubular sheath covering the second flexible tube.

According to further features in preferred embodiments of the inventiondescribed below, the first flexible tube is constructed from a spirallywound wire.

According to still further features in the described preferredembodiments the second flexible tube is constructed from a spirallywound wire.

According to still further features in the described preferredembodiments the device further comprises the tissue anchor.

According to still further features in the described preferredembodiments the tissue anchor is attached to the rigid distal portionand disposed within the second flexible tube.

According to still further features in the described preferredembodiments the first flexible tube can be advanced within the secondflexible tube when the first and the second flexible tubes areconstrained along a non-linear path.

According to still further features in the described preferredembodiments the second flexible tube can be advanced within the tubularsheath.

According to still further features in the described preferredembodiments advancing the first flexible tube within the second flexibletube ejects the tissue anchor from the flexible tube.

According to still further features in the described preferredembodiments the tissue anchor is configured such that a portion thereofincreases in diameter when ejected from the second flexible tube.

According to another aspect of the present invention there is provided asystem for delivering an anchor to tissue comprising: (a) a housingadapted for attachment to an ultrasound probe, the housing including atleast one guide disposed thereupon; (b) a device for tissue anchordelivery including: (i) a first flexible tube having a rigid distalportion attachable to a tissue anchor; (ii) a second flexible tubecoaxially disposed around the first tube; and (iii) a tubular sheathcovering the second flexible tube; the device being attachable to the atleast one guide such that when the housing is attached to the ultrasoundprobe, the rigid distal portion can be longitudinally aligned with animage plane of the ultrasound probe.

The present invention successfully addresses the shortcomings of thepresently known configurations by providing a transvaginal ortrans-rectal/anal anchor delivery system which enables accurate deliveryand anchoring of an attached suture or mesh to an anatomical landmark inthe pelvic floor while minimizing trauma and eliminating risk tosurrounding tissue and organs.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present invention, suitable methods andmaterials are described below. In case of conflict, the patentspecification, including definitions, will control. In addition, thematerials, methods, and examples are illustrative only and not intendedto be limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the present invention only, and are presentedin the cause of providing what is believed to be the most useful andreadily understood description of the principles and conceptual aspectsof the invention. In this regard, no attempt is made to show structuraldetails of the invention in more detail than is necessary for afundamental understanding of the invention, the description taken withthe drawings making apparent to those skilled in the art how the severalforms of the invention may be embodied in practice.

In the drawings:

FIG. 1 illustrates one embodiment of the imaging device coupler havingtwo guide tubes, one loaded with an anchor delivery device.

FIGS. 2A-B are views of the device coupler of FIG. 1, showing the distaltip of the anchor delivery device extending out of the guide tube (FIG.2A), and the anchor extending out of the distal tip of the guide tube(FIG. 2B).

FIG. 3 illustrates the imaging device coupler of FIG. 1 mounted on anultrasound transducer showing the alignment between the imaging field ofthe transducer (F) and the path of the guide tubes.

FIG. 4 illustrates the imaging device coupler of FIG. 1 mounted on anultrasound transducer showing the alignment between the imaging field ofthe transducer (F) and the delivery path of the anchor.

FIGS. 5A-D illustrate the anchor delivery device of the presentinvention, showing the handle and tube assembly in non-deployed (FIGS.5A-B) and deployed (FIGS. 5C-D) states.

FIGS. 6A-F illustrate one embodiment of a tissue anchor constructed inaccordance with the teachings of the present invention.

FIG. 7 is an ultrasound image showing the SSL.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is of a system and method which can be used todeliver tissue anchors and optionally anchor-attached devices (e.g.sling/mesh) to anatomical landmarks in the pelvic floor in order torepair pelvic floor disorders such as pelvic organ prolapse (POP).

The principles and operation of the present invention may be betterunderstood with reference to the drawings and accompanying descriptions.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description, Example or drawings. The inventionis capable of other embodiments or of being practiced or carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein is for the purpose of description and shouldnot be regarded as limiting.

Pelvic organ prolapse (POP), and especially apical central supportivedefect (ACSD), significantly affects the quality of life of about 20% ofthe female population. POP is typically corrected via a transabdominalor a transvaginal surgical procedure.

The transvaginal reconstruction approach is regarded as superior to thetransabdominal approach due to a shorter operative time and hospitalstay and quicker rehabilitation. However, transvaginal proceduresrequire advanced surgical skill and as such are performed by a rathersmall and highly qualified group of surgeons.

In the transvaginal procedure, a surgeon can elect to suspend thevaginal apex (VA) or the uterine cervix (UC) to thesacrospinous-ligament (SSL), sacrum, arcus tendineous fascia pelvis(ATFP) or other potentially solid supportive pelvic structures, whichare accessed via anterior or posterior vaginal wall incisions and bluntdissection of tissues.

Creating an access path to these tissues is a major challenge oftransvaginal procedures since it requires complicated navigation to thepelvic side wall (PSW), ischial spine (IS) and then to the mid SSL(MSSL) or the sacrum which carries with it a risk of damaging thebladder, rectum, blood vessels, nerves, ureters, etc.

Most POP procedure complications are attributed to the dissectionnecessary to create the tissue path to the elected tissue support site.

In order to traverse these limitation of prior art transvaginalprocedures, the present inventors have devised a system which is capableof accessing anatomical landmarks within the pelvic floor and accuratelydelivering a tissue anchor thereto while minimizing tissue trauma andcomplications.

As used herein, the phrase “pelvic floor disorder” refers to anydisorder of the pelvic floor that is associated with prolapse,herniation or incorrect anatomical positioning of pelvic floor tissues.

The term “repair” when used herein with reference to pelvic floordisorders refers to correction (complete or incomplete) of anatomy, via,a tissue repair device such as a suture, a mesh, a sling and/or thelike. An example of a repair procedure effected using the presentmethodology and system is described below.

Thus according to one aspect of the present invention there is provideda system for delivering a device such as an anchor (attached to a sutureor mesh) to a tissue.

The system includes a housing (also referred to herein as coupler)adapted for attachment to an imaging probe, such as an ultrasound probe.The coupler includes at least one guide disposed thereupon for acceptinga device for tissue anchor delivery (also referred to herein as deliverydevice or anchor delivery device).

The guide(s) are constructed from a rigid tube.

The coupler and guide are configured such that when the coupler isattached to the imaging probe, the rigid distal portion of the deliverydevice can be longitudinally aligned with an image plane of the imagingprobe.

The imaging device can be any type of imaging device suitable for tissueimaging from within the rectal or vaginal cavity. Examples of suitableimaging devices include infrared imaging devices and the like. Suchdevices are configured so as to enable insertion into, and use withinthe cavity of choice.

In a preferred embodiment of the present system, the imaging probe is anultrasound transducer with an imaging plane that projects at an angle(e.g. 45-90 degrees) with respect to the longitudinal axis of the probe.The coupler and attached guide(s) are configured so as to enable thedistal tip of the delivery device to align with the imaging plane of theprobe such that an anchor is delivered parallel to and within theimaging plane of the probe, i.e. it is delivered into an imaged tissueplane.

FIGS. 1-4 illustrate one embodiment of the present system which isreferred to herein as system 10.

FIG. 1 illustrates coupler 12 having two delivery guides 14 configuredas tube-like channels. In this embodiment of coupler 12, delivery guides14 include proximal guide tube portion 16 and distal guide tube 18portion.

Coupler 12 can include any number of guides 14, the embodiment of FIGS.1-4 are of a coupler 12 that includes two side mounted guides 14 thatenable anchor delivery from either or both sides of coupler 12.

Coupler 12 is roughly trough-shaped (with open proximal and distal ends)and is constructed from a polymer such as ABS or Polycarbonate with alength of 80-120 mm, width of 25 and a height of 20-30 mm. Coupler 12can include a handle for delivery into a cavity, or alternatively, ahandle of an attached imaging device can be used for such purposes.

Coupler 12 includes a probe coupling interface 20 for accepting andreversibly attaching to an imaging probe such as an ultrasound probe. Inone embodiment of coupler 12, the imaging probe snaps into interface 20and is longitudinally aligned therewith with the imaging head occupyinga predetermined longitudinal position at distal end 22 of coupler 12.This ensures that the imaging head of the imaging probe and itsprojected image plane are a known distance (longitudinally) from distalguide tube 18.

System 10 also includes an anchor delivery device 33 which isconstructed from two coaxial tubes. A first flexible tube 32 (shown inFIGS. 2A-B) attached to a tissue anchor 30 (shown in FIG. 2B). A rigidguide 14 is coaxially disposed around anchor delivery device 33. Thetubes of anchor delivery device 33 can be pushed out of rigid guide 14to deliver tissue anchor 30 via rigid distal portion 18 of guide tube14. To effect such delivery, delivery device includes a handle 31 foractuating forward movement (in a distal direction) of first flexibletube 32 within guide tube 14.

Delivery device 33 is preferably capable of puncturing the vaginal walland driving tissue anchor 30 through the tissue and into the targetsite. As such, distal end 28 of first flexible tube 32 can be configuredfor tissue puncturing (beveled, double beveled or conical).Alternatively, tissue anchor 30 can be configured for tissue puncturingor still alternatively an initial incision in the vaginal wall can beused to deliver first flexible tube 32 therethrough. Distal portion 28(and/or anchor 30) can also include an imaging marker for identifyingthese elements within the imaging plane. An example of an echogenicmarker which can be used along with an ultrasound probe is provided inUS20050228288. Delivery device 33 is described in more detailhereinbelow with reference to FIGS. 5A-D, while anchor 30 is describedin more detail hereinbelow with reference to FIGS. 6A-F.

FIG. 3 illustrates coupler 12 attached to an imaging probe 36(vaginal/anal ultrasound probe illustrated) with imaging head 38protruding from a distal end 22 of coupler 12. Imaging field (plane) ofimaging head 38 is indicated by F and is about 70 degrees (forward tilt)with respect to the longitudinal axis of imaging probe 36.

The angle of distal guide tube portions 18 can either be fixed to thetype of probe 36 used or it can be manually adjusted (by rotating) andlocked in a rotational position suitable for the imaging plane of theimaging probe used.

In any case, the angle of distal guide tube portions 18 is aligned withthe imaging plane (F) such that distal portion 28 delivers an anchor 30into and parallel with imaging plane F. Plane (F) is thinner than distalportion 28 (2.5 mm) such that distal portion 28 is always visible onscreen. FIG. 4 illustrates an anchor 30 with an attached suture 43delivered into the imaging plane (and thus the tissue viewed therein),distal portion 28 of first tube 32 is not shown.

FIGS. 5A-B illustrate handle 31 in its idle (pre-deployed) position.Trigger 40 protects button 42 from being pressed prematurely. Button 42is connected to first flexible tube 26. Button 42 is held in its idleposition by force applied by spring 41.

FIGS. 5C-D illustrate handle 31 in the deployed position. Rotation oftrigger 40 enables an operator to access button 42, which when pressed,actuates first flexible tube 26 to deploy (push out) anchor 30.

Flexible portion of tubes 26 and 32 can be made from a flexible polymeror a preloaded spring.

FIGS. 6A-B illustrate anchor 30 constrained by distal portion 28 of tube32.

Anchor 30 is in contact with flexible portion of tube 26. FIGS. 6C-Dillustrate anchor 30 in its unconstrained position after being pushedout of distal portion 28 of tube 32. Anchor 30 is shown in itsunconstrained position. FIG. 6E illustrates anchor tube 44 and anchortip 45 of anchor 30 and attached suture 43.

FIG. 6F illustrates anchor 30 in its unassembled state. Anchor tube 44and anchor tip 45 are composed of nitinol or a polymer such as PEEK.They can be laser welded together or alternatively connectedmechanically via a snap. Suture 43 is composed of prolene or anysurgical suture material. Anchor 30 can be 2 mm in diameter and 8 mm inlength. Anchor 30 can be configured with a pull out force of about 30N.

One preferred use for system 10 is in centro-apical reconstructionprocedures.

Such procedures are the key to proper pelvic organ prolapse (POP)repair. The premium supportive pelvic structure is the sacrospinousligament (SSL), positioned at the posterior aspect of the pelvis. TheSSL is high, thus provides a level 1 support by DeLancey. The SSL is astable anatomical landmark and as such it is highly suitable foranchoring support.

System 10 can be used in centro-apical reconstruction procedures bypositioning coupler 12 with attached probe 36 in a rectal, anal orvaginal cavity (using handle 37 of probe 36 or a handle incorporatedinto coupler 12), inserting delivery device 33 through guides 14, andadvancing distal portion 28 of delivery device 33 (with attached anchor30) through a vaginal wall under guidance of an ultrasound probe tothereby reach a target tissue within the pelvic floor (e.g. SSL). Onceat the target tissue, anchor 30 can be deployed into the target tissueby advancing first flexible tube 26 within second flexible tube 32 usinghandle 31.

Imaging enables direct visualization of the MSSL and alignment betweenthe imaging plane and distal portion 28 of delivery device 33 enablesaccurate navigation of anchor 30 thereto providing a surgeon withtransvaginal access to the MSSL through the lateral vaginal wall andminimizing risks associated with posterior or anterior access (injury tothe rectum or bladder).

A transvaginal pelvic organ prolapse (POP) repair procedure using system10 is described in greater detail below.

An ultrasound probe is coupled to coupler 12 and an anchor 30 is loadedinto system 10. System 10 is positioned in the vaginal cavity andsecured to the uterine cervix. The US probe is activated and theposterior compartment of the pelvic floor is scanned, to locate the SSL.Color Doppler is activated to rule out any blood vessel on the imaginarytarget of the anchoring needle, towards the MSSL (or any other ligamentsegment). Anchor 30 is deployed as described above on one lateralvaginal fornix, and initial pull out force is measured to verifyfixation. This is optionally repeated on the other side. System 10 isremoved from the vaginal cavity and the free sutures entering the vaginaare needle passed back beyond the vaginal wall and sutured to thecervical fibrotic ring, via a small colpotomy.

The present coupler and delivery device (the present system) can be usedto perform transvaginal pelvic floor procedures with ease and whileminimizing tissue damage and trauma. The present system is advantageousin that:

(i) it does not require posterior or anterior vaginal dissections whichcan jeopardize the rectum or bladder;

(ii) it enables direct visualization of the target tissue (e.g. MSSL)for accurate navigation of a minimally invasive surgical instrument;

(iii) US provides a clear image of the surgical instrument tip at thetarget tissue (e.g. MSSL), since the imaging plane and anchor arealigned;

(iv) it minimizes unwanted damage to visceral and vessel tissue duringthe procedure; and

(v) it eliminates the need for deep pelvic manual dissection andHydrodissection.

As used herein the term “about” refers to ±10%.

Additional objects, advantages, and novel features of the presentinvention will become apparent to one ordinarily skilled in the art uponexamination of the following examples, which are not intended to belimiting.

EXAMPLES

Reference is now made to the following example, which together with theabove descriptions, illustrate the invention in a non limiting fashion.

SSL Imaging

An angled vaginal ultrasound (Side Fire) probe was utilized in order tovisualize the SSL. As is shown in FIG. 7, the MSSL is easilydemonstrated (arrow) with angled US probe as it is attached to thesacrum at its mid-level and goes laterally. The tissue surrounding theSSL is the piriformis muscle, also easily detected via angled ultrasoundimaging.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

What is claimed is:
 1. A system for attaching an anchor to a ligamentlocated outside of a vaginal wall, the system comprising: a vaginallyinsertable assembly extending along a longitudinal axis, said vaginallyinsertable assembly having a trough-shaped with an open proximal end andan open distal end; a working channel fixed to said vaginally insertableassembly and extending along at least an elongate portion thereof at anangle with respect to said longitudinal axis, said working channelhaving a distal end, which is fixed with respect to the vaginallyinsertable assembly at a location which is not forward of said distalend of said vaginally insertable assembly; and a suture and penetratinganchor assembly which is configured to be displaceable at least alongsaid elongate portion of said working channel through said vaginal walland into anchoring relationship with said ligament.
 2. A systemaccording to claim 1 and wherein said suture and penetrating anchorassembly comprises a laterally expandable anchor.
 3. A system accordingto claim 1 and wherein said suture and penetrating anchor assembly isconfigured to remain at said angle with respect to said longitudinalaxis when displaced through said vaginal wall into said anchoringrelationship with said ligament.